Update of the Stroke Therapy Academic Industry Roundtable Preclinical Recommendations
Top Cited Papers
- 1 June 2009
- journal article
- review article
- Published by Ovid Technologies (Wolters Kluwer Health) in Stroke
- Vol. 40 (6), 2244-2250
- https://doi.org/10.1161/strokeaha.108.541128
Abstract
The initial Stroke Therapy Academic Industry Roundtable (STAIR) recommendations published in 1999 were intended to improve the quality of preclinical studies of purported acute stroke therapies. Although recognized as reasonable, they have not been closely followed nor rigorously validated. Substantial advances have occurred regarding the appropriate quality and breadth of preclinical testing for candidate acute stroke therapies for better clinical translation. The updated STAIR preclinical recommendations reinforce the previous suggestions that reproducibly defining dose response and time windows with both histological and functional outcomes in multiple animal species with appropriate physiological monitoring is appropriate. The updated STAIR recommendations include: the fundamentals of good scientific inquiry should be followed by eliminating randomization and assessment bias, a priori defining inclusion/exclusion criteria, performing appropriate power and sample size calculations, and disclosing potential conflicts of interest. After initial evaluations in young, healthy male animals, further studies should be performed in females, aged animals, and animals with comorbid conditions such as hypertension, diabetes, and hypercholesterolemia. Another consideration is the use of clinically relevant biomarkers in animal studies. Although the recommendations cannot be validated until effective therapies based on them emerge from clinical trials, it is hoped that adherence to them might enhance the chances for success.Keywords
This publication has 39 references indexed in Scilit:
- REPRINT: Good Laboratory Practice: Preventing Introduction of Bias at the BenchInternational Journal of Stroke, 2009
- Long-Lasting Functional Disabilities in Middle-Aged Rats with Small Cerebral InfarctsJournal of Neuroscience, 2003
- Functional and Histological Evidence for the Protective Effect of NXY-059 in a Primate Model of Stroke When Given 4 Hours After OcclusionStroke, 2003
- Polymorphism in soluble epoxide hydrolase and blood pressure in spontaneously hypertensive rats.Hypertension, 2002
- Admission glucose level and clinical outcomes in the NINDS rt-PA Stroke TrialNeurology, 2002
- Recommendations for Standards Regarding Preclinical Neuroprotective and Restorative Drug DevelopmentStroke, 1999
- Improving the quality of reporting of randomized controlled trials. The CONSORT statementJAMA, 1996
- Tissue Plasminogen Activator for Acute Ischemic StrokeThe New England Journal of Medicine, 1995
- The evolution of acute stroke recorded by multimodal magnetic resonance imagingMagnetic Resonance Imaging, 1993
- Tissue Plasminogen Activator Reduces Neurological Damage After Cerebral EmbolismScience, 1985